Overview

This trial is active, not recruiting.

Condition early amniotomy, unfavorable cervix
Treatment pge2
Phase phase 2
Sponsor Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Start date August 2016
End date October 2016
Trial size 200 participants
Trial identifier NCT02856724, 145

Summary

This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
10 mg PGE2 vaginal ovul(Propess) Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.
pge2 dinoprostone
10 mg PGE2 vaginal ovul(Propess)
(Active Comparator)
10 mg PGE2 vaginal ovul(Propess)
pge2 dinoprostone
10 mg PGE2 vaginal ovul(Propess)

Primary Outcomes

Measure
induction-to- delivery time
time frame: delivery (the length of time between the beginning of induction and the end of labor)

Secondary Outcomes

Measure
mode of labor (vaginal or C-section)
time frame: delivery
successful induction
time frame: vaginal delivery within 24 h from the beginning of induction

Eligibility Criteria

Female participants from 18 years up to 40 years old.

Inclusion criteria 1. singleton pregnancy, 2. gestational age ≥34 weeks, 3. intact membranes, 4. cephalic presentation, 5. bishop score ≤5, 6. had obstetrical indications for induction of labor, 7. had less than three uterine contractions in every 10 minutes. Exclusion Criteria: 1. Patients who have contraindications for vaginal delivery, 2. previous uterine surgery, 3. fetal malpresentation, 4. multifetal pregnancy, 5. more than three contractions in 10 minutes, 6. contraindications to prostaglandins, 7. a category II or III fetal heart rate pattern, 8. anomalous fetus, 9. fetal demise 10. women with immediate delivery indications -

Additional Information

Description During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.